The following data is part of a premarket notification filed by United Dental Mfg., Inc. with the FDA for File Type H (hedstroem) Endodontic.
| Device ID | K823685 |
| 510k Number | K823685 |
| Device Name: | FILE TYPE H (HEDSTROEM) ENDODONTIC |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | UNITED DENTAL MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-07 |
| Decision Date | 1982-12-28 |